To Determine the Prevalence of HIV and Other Related Infections Such as Hepatitis C, Along With Associated Risk Behaviors, in Patients With Severe Mental Illness (SMI).

February 2, 2011 updated by: US Department of Veterans Affairs

CSP #706D - HIV Seroprevalence and Risks in Veterans With Severe Mental Illness

It is suspected, but not well documented, that persons with severe mental illness (SMI) represent a significant transmission source of serious infectious diseases. SMI diagnoses are defined as schizophrenia, schizoaffective disorder, bipolar disorder, or posttraumatic stress disorder (PTSD). Severely mentally ill persons are at high risk for Human Immunodeficiency Virus/Acquired Immunodeficiency Syndrome (HIV/AIDS). To assess the risk of HIV and related infections among these individuals, the National Institute of Mental Health (NIMH) Office on AIDS funded the HIV/SMI five site collaborative study "Assessing HIV/AIDS and Associated Health Risks in People with Severe Mental Illness". This Durham ERIC study supplements the NIMH HIV/SMI study with a four-year longitudinal cohort study of 300-plus SMI veterans in order to estimate the prevalence of HIV risk behaviors and HIV infection, as well as to measure utilization of health services over time. The Durham VA is the only VA site represented in the study and is collaborating with four non-VA sites including Dartmouth, University of New Hampshire, University of Connecticut and Duke University. As such, we have the additional goals of investigating health and health-care-service issues relevant to veterans with SMI and of establishing a database for the longitudinal study of veterans with SMI.

Study Overview

Status

Completed

Conditions

Detailed Description

Primary Objectives: To determine the prevalence of HIV and other related infections such as Hepatitis C, along with associated risk behaviors, in patients with severe mental illness (SMI).

Secondary Objectives: To identify the implications for mental health and medical services and to obtain a better understanding of the contextual factors that affect the health problems associated with HIV risk behavior.

Primary Outcomes: The primary outcome variables are HIV seroprevalence, prevalence of HIV risk behaviors including injection drug use and sexual promiscuity, personal and social-contextual factors, comorbid mental disorders, and health service use among SMI persons in each group, veterans versus non-veterans.

Intervention: N/A

Study Abstract: It is suspected, but not well documented, that persons with severe mental illness represent a significant transmission source of serious infectious diseases. SMI diagnoses are defined as schizophrenia, schizoaffective disorder, bipolar disorder, or posttraumatic stress disorder (PTSD). Severely mentally ill persons are at high risk for Human Immunodeficiency Virus/Acquired Immunodeficiency Syndrome (HIV/AIDS). To assess the risk of HIV and related infections among these individuals, the National Institute of Mental Health (NIMH) Office on AIDS funded the HIV/SMI five site collaborative study "Assessing HIV/AIDS and Associated Health Risks in People with Severe Mental Illness". This Durham ERIC study supplements the NIMH HIV/SMI study with a four-year longitudinal cohort study of 300-plus SMI veterans in order to estimate the prevalence of HIV risk behaviors and HIV infection, as well as to measure utilization of health services over time. The Durham VA is the only VA site represented in the study and is collaborating with four non-VA sites including Dartmouth, University of New Hampshire, University of Connecticut and Duke University. As such, we have the additional goals of investigating health and health-care-service issues relevant to veterans with SMI and of establishing a database for the longitudinal study of veterans with SMI.

Study participation consisted of a one-hour structured HIV-risk behavior interview and a blood and urine sample. These samples are being tested for HIV, syphilis, hepatitis B and C, cytomegalovirus, gonorrhea, and chlamydia at the Durham VA Microbiology Laboratory. Subject enrollment for this study concluded 6/30/2000 with 399 total subjects enrolled. Of these 399 enrolled, 111 subjects were re-tested and re-interviewed. The percentage of subjects enrolled at the Durham VAMC with infectious diseases is as follows: 2.6% with HIV infection; 21% with Hepatitis B core antibodies; and, 18% with Hepatitis C antibodies. Clinical management of subjects with positive serology continues to be administered according to the procedures developed by Richard Frothingham, M.D.

Final Results: The initial manuscript for the study was published in American Journal of Public Health in January, 2001 and analyses for additional publications are underway. Final Report to be submitted to Durham ERIC within 90 days of study end date (3/31/02).

Study Type

Observational

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • North Carolina
      • Durham, North Carolina, United States, 27705
        • VA Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

SMI veterans

Exclusion Criteria:

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Cohorts and Interventions

Group / Cohort
1

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

US Department of Veterans Affairs

Investigators

  • Study Chair: Marian I. Butterfield, MD MPH, VA Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 1998

Study Registration Dates

First Submitted

December 29, 2000

First Submitted That Met QC Criteria

December 30, 2000

First Posted (Estimate)

January 1, 2001

Study Record Updates

Last Update Posted (Estimate)

February 3, 2011

Last Update Submitted That Met QC Criteria

February 2, 2011

Last Verified

February 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 706D

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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